A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.
Generalized Anxiety Disorder
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Toludesvenlafaxine Hydrochloride Sustained-release Tablet, generalized anxiety disorder, efficacy, safety
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 to 65 years subjects; Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for Generalized Anxiety Disorder; Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and baseline; Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline; Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening and baseline. Exclusion Criteria: Meet the diagnostic criteria for other psychotic disorders(defined by DSM-5, except for GAD), including major depression disorder within 6 months prior to screening , presence or history of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic stress disorder, anorexia nervosa or bulimia and personality disorder; Meet the diagnostic criteria for substance or alcohol abuse (defined by DSM-5, except for nicotine or caffeine) within 6 months prior to screening; Have anxious symtoms secondary to other physical illnesses or mental illnesses and anxious induced by psychoactive substance; Withdrawal psychotropic drugs within 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors, at least 1 month for fluoxetine, and at least 2 weeks for benzodiazepines or barbiturates) prior to randomization; Have received psychosurgery or physical therapy for psychiatric illness (such as transcranial magnetic stimulation) within 3 months prior to screening; Have received systematic psychotherapy or other non-drug therapies for psychiatric disorders (such as acupuncture or light therapy) within 6 weeks prior to screening; Concomitant with serious and unstable illness, including cardiovascular, hepatic, renal, hematological, endocrine illness, malignant tumors and other physical illness; Have a history of seizures (except for seizures caused by febrile convulsions in childhood); Have a history of gastrointestinal disease or surgery known to interfere with investigation product absorption or excretion; Known or suspected allergic or severe reaction to investigation product or inactive ingredients; or allergic to venlafaxine or desvenlafaxine; or allergic constitution (defined as allergic to two or more drugs or food) and unfit to participate judged by investigator;
Sites / Locations
- Peking University Sixth Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Sham Comparator
Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group
Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group
Placebo
orally once a day
orally once a day
orally once a day